Urethral anastomosis device

Abstract

Provided is a device for urethral anastomosis, for example, following prostatectomy. The device has a flexible slender shaft including a flexible outer sleeve and a flexible inner sleeve inside a lumen of the outer sleeve. A bladder anchoring system anchors the distal end of the inner sleeve inside a urinary bladder, and a urethral anchoring system anchors the outer sleeve in a urethral stump. A ratchet mechanism allows proximal movement of the inner sleeve inside the outer sleeve while preventing distal movement of the inner sleeve inside the outer sleeve. The device is used to urge the urinary bladder towards the internal termination of the urethra to allow anastomosis of the bladder neck to the urethral stump.

1 .- 11 . (canceled) 
     
     
         12 . A urethral anastomosis device having a proximal end and a distal end and comprising:
 (a) a flexible slender shaft comprising a flexible outer sleeve and a flexible inner sleeve inside a lumen of the outer sleeve;   (b) a bladder anchoring system configured to anchor the distal end of the inner sleeve inside a urinary bladder;   (c) a urethral anchoring system configured to anchor the outer sleeve in a urethral stump and further configured to allow urine to pass through the urethral anchoring system; and   (d) a ratchet mechanism allowing proximal movement of the inner sleeve inside the outer sleeve while preventing distal movement of the inner sleeve inside the outer sleeve.   
     
     
         13 . The device according to  claim 12 , wherein the bladder anchoring system comprises balloon configured to be inflated in the urinary bladder. 
     
     
         14 . The device according to  claim 13 , wherein the balloon has an ellipsoid shape when inflated. 
     
     
         15 . The device according to  claim 12 , wherein the ratchet mechanism comprises:
 (a) a flexible cylinder consisting of an array of circular asymmetric ratchet teeth surrounding the inner sleeve; and   (b) a rigid cylinder attached to an inner surface of the outer sleeve and having a pawl configured to engage the ratchet teeth of the flexible cylinder.   
     
     
         16 . The device according to clam  12 , wherein the urethral anchoring system comprises:
 (a) a cylindrical array of pointed tines surrounding the outer sleeve, the tines having an undeployed configuration in which the tines are in an undeployed position parallel to an outer surface of the outer sleeve and a deployed position in which the tines are splayed outward from the surface of the outer sleeve; and   (b) a tines balloon located inside the cylindrical array of tines, inflation of the tines balloon causing the tines to move from the undeployed position of the tines to the deployed position of the tines.   
     
     
         17 . The device according to  claim 16 , wherein the urethral anchoring system further comprises a collapsing sleeve surrounding the cylindrical array of tines, the collapsing sleeve causing the tines to move from the deployed configuration of the tines to the undeployed configuration of the tines when the tines balloon is not inflated. 
     
     
         18 . The device according to  claim 16 , wherein each tine is provided with a hinge. 
     
     
         19 . The device according to  claim 16 , wherein each tine has a point including a shoulder. 
     
     
         20 . The device according to  claim 16 , wherein the tines balloon has a cylindrical shape. 
     
     
         21 . The device according to  claim 12 , further comprising a funnel assembly at the proximal end of the device comprising:
 (a) a first opening confluent with a lumen of the inner sleeve configured to drain urine from the urinary bladder after deployment of the device in a urinary tract;   (b) a second opening confluent with a longitudinal passageway in the wall of the inner sleeve for delivering an inflation medium, to an interior of the bladder balloon in order to inflate the bladder balloon; and   (c) a third opening confluent with a passageway in the wall of the outer shaft for delivering an inflation medium to the tines balloon in order to inflate the tines balloon.   
     
     
         22 . A method for urethral anastomosis between a urinary bladder neck and a urethral stump comprising:
 (a) inserting the distal end of the device according to any one of the previous claims through a urinary meatus into the urethral stump until the distal end of the device is located inside the bladder;   (b) anchoring the distal end of the device inside the urinary bladder by the bladder anchoring system;   (c) sliding the inner sleeve of the device proximally inside the outer sleeve until the bladder neck is in contact with an internal termination of the urethral stump; and   (d) anchoring the distal end of the outer sleeve in the urinary stump by the urethral anchoring system.